A Multicenter Phase II Open Label Non-Comparative Trial of RP56976 Administered Every Three Weeks in Combination With Daily Prednisolone for Metastatic Hormone Refractory Prostate Cancer
Phase 2
20 Years
74 Years
20 Years
74 Years
Not Enrolling
Male
Prostatic Neoplasms
Male
Prostatic Neoplasms
Trial Information
A Multicenter Phase II Open Label Non-Comparative Trial of RP56976 Administered Every Three Weeks in Combination With Daily Prednisolone for Metastatic Hormone Refractory Prostate Cancer
Inclusion Criteria:
- Men with prostate adenocarcinoma with at least one metastatic lesion which is
measurable and who progressed after prior hormonal therapy.
Exclusion Criteria:
- 1.Body temperature > 38 degree centigrade.
- 2.Prior radiotherapy to > 25% of bone marrow.
- 3.Prior isotope therapy and/or brachytherapy
- 4.Prior gene therapy.
- 5.Active double cancer.
- 6.Known brain or leptomeningeal involvement.
- 7.History of hypersensitivity reaction to drug
- 8.Other serious illness or medical condition
- 9.Subjects whom the investigators consider inappropriate from social or medical
aspects.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall tumor response rate by Response Evaluation Criteria in Solid Tumor (RECIST)
Principal Investigator
Atsushi NAKAMURA
Investigator Role:
Study Chair
Investigator Affiliation:
CSD, PL / TA-Oncology
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
ARD6562
NCT ID:
NCT00291005
Start Date:
August 2004
Completion Date:
Related Keywords:
- Prostatic Neoplasms
- Prostate cancer
- HRPC
- AIPC
- Hormone refractory
- Androgen independent
- Docetaxel
- Taxotere
- prednisolone
- Neoplasms
- Prostatic Neoplasms
Name | Location |
|---|
